A Prospective Open-label Randomized Controlled Trial , Evaluating the Efficacy of Ursodeoxycholic Acid (UDCA) as an Adjuvant to Phototherapy in Neonates With Indirect Hyperbilirubinemia

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective, open-label, randomized controlled trial conducted at Lattakia University Hospital (Tishreen University), aiming to evaluate the efficacy of Ursodeoxycholic Acid (UDCA) as an adjuvant to triple phototherapy in the management of indirect hyperbilirubinemia in neonates ≥34 weeks of gestation. Eligible neonates will be randomly assigned to one of two groups: Group A: continuous triple phototherapy only Group B: UDCA (10 mg/kg/day in two oral doses) in addition to triple continuous phototherapy. Stratified randomization will be applied according to etiology (hemolytic, non-hemolytic, G6PD deficiency). The primary outcome is the rate and time of decline in total and indirect serum bilirubin to below phototherapy thresholds, monitored every 12 hours until discharge. This trial seeks to determine whether UDCA may reduce phototherapy duration or enhance bilirubin clearance in a safe and effective manner. Although this is an open-label trial for care providers and participants , the statstican conducting data analysis will be blinded to group allocation to reduce assessment bias.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 month
Healthy Volunteers: f
View:

• Neonates with gestational age ≥ 34 weeks

• Appropriate for Gestational Age (AGA) infants

• Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy.

Locations
Other Locations
Syrian Arab Republic
Lattakia University Hospital
RECRUITING
Latakia
Contact Information
Primary
Ashraf M Alshelly, MD, Ped.Res.
Ashraf.m.alshelly@tishreen.edu.sy
+963930052903
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 70
Treatments
Active_comparator: Group A - phototherapy only
Infants who have indirect hyperbilirubinemia recieve continuous triple phototherapy only .
Experimental: Group B - phototherapy + UDCA
Phototherapy + UDCA
Sponsors
Leads: Tishreen University Hospital

This content was sourced from clinicaltrials.gov